The invention relates to a rhinological implant for straightening the nasal septum, which can be fastened on both sides of the septum of the human nose on the outer surface of the septum in each case in the left and right sides of the nasal cavity. Before implantation, the implant is folded up from an initially flat blank into the subsequent implantable, three-dimensional shape thereof.
Such an implant for straightening the septum is known to be available from Bess Medizintechnik GmbH, headquartered in Berlin, Germany, from 26 Jul. 2012.
A method of implanting such an implant (i.e., a tissue piece or substance that is usually exogenous), into the human body is known for a long time in medical technology and is carried out in many variations to eliminate functional defects of various body parts and/or psychic impairments.
It also is known that the cartilaginous portion of the human nose comprises the nasal septum, the triangular cartilage, and the alar cartilage.
In functional and cosmetic nasal surgery, the objective in many cases is to straighten the septum in order to improve the air flow within the nasal passage or, to simply improve the appearance of the nose. Such known procedures also typically include changing other structures.
Presently, different suturing or cartilage transplant techniques are used to straighten the septum. In the following, the differences between septoplasty and the collumellar strut technique will be discussed.
In greater detail, the sole objective of septoplasty is to straighten the septum and, therefor, optimize the air inflow through the nose. This surgery is purely functional. A variety of surgical techniques is used therefor, which utilize sutures and transplants to achieve the objective.
The straightening of a deviated septum can be one of the greatest challenges in rhinoplasty. Various methods, which depend substantially on the experience and expertise of the operating surgeon, may be used for this purpose.
Disarticulation techniques, up to and including specific cartilage incisions, can play a greater or lesser role. Straightening the septum specifically in the central arch is a difficult undertaking and is hardly a simple operation.
In contrast to a straightening of the septum, the objective of the collumellar strut technique is to raise the tip of the nose for cosmetic reasons. In the collumellar strut technique, a strut is slid between the two ends of the two alar cartilages in order to raise the tip of the nose. The graft/implant is placed into a pocket between the medial crura of the alar cartilages over the Spina nasalis anterior and is fastened between the medial crura using sutures extending therethrough.
This technique is described in US 2012/0078367 A1, for example. The implant discussed therein is biodegradable and, therefore, is not intended to remain in place for a long period of time. The target region is the lower third of the nose, mainly the region around the nasal tip. This technique also involves connecting the implant to the septum but not straightening the septum. Instead, the technique involves extending the septum if the septum has been shortened due to an external influence or, is short from a cosmetic perspective. The curved parts of the above-described implant do not exceed 20 mm in length in the longitudinal extension thereof. When placed onto the base of the Spina nasalis, the curved parts extend just to the end of the septum and accommodate the two crura of the alar cartilages. Therefore, the septum is never straightened. In the seat of the implant in the implanted state would be entirely unsuitable for septum straightening.
Document WO 2008/153263 A1 describes techniques that are designed to raise the nasal tip, where the septum also is discussed in that case. In the technique described therein, the implant must be placed at the upper edge of the septum cartilage. In that case, the objective is to stabilize the nasal tip implant.
Known implant systems according to US 2012/0078367 A1 and, WO 2008/153263 A1, are known to disclose techniques which attempt to utilize the end of the septum for stabilization or extension. However, neither of the two systems is designed or suitable for permanently straightening the septum.
In order to straighten the septum, it is known to apply techniques using PDS plates (e.g. described in: HNO.1999 June; 47 (6):546-50), which are cut to fit and are sutured onto the septum. The extremely thin plate implants resorb after 10 to 25 weeks, leaving substantially no residue.
Also known are Reuter-type intranasal splints made of silicone that are known to be available from Bess Medizintechnik GmbH, headquartered in Berlin, Germany Reuter-type intranasal splints are more stable implants for straightening the septum. These implants are used for the splinting of the nasal septum and to minimize the risk of adhesion between the septum and the lateral nasal wall. Reuter-type intranasal splints are designed with a slit for smoother insertion and removal and comprise pre-punched holes for suture fixation. The material from which Reuter-type intranasal splints are made is said to be fluoroplastic. However, the splints must be removed from the nose after a few weeks since silicone is not stable over the long term and potentially leads to infections.